Lineum HF Torque Handle Limit (Lineum) Model Number 14-525035 P_roduct Usage: Designed to facilitate reconstruction of t

FDA device recall Z-1465-2015 · posted 2015-04-20 · Terminated

Recall details

Recalling firm

Biomet Spine, LLC

Reason for recall

Biomet is recalling the Lineum HF Torque Handle Limit (Lineum) and Torque Limiting Handle (Aspen/ Alpine) due to the supplier withdrawing it from the market for component updates or reconfiguration.

Action taken

Biomet sent an Urgent Medical Device Recall Notice dated March 12, 2015 via phone and customer letters. The letter identified the affected product, problem and actions to be taken. Customers were asked to follow the instructions on the enclosed "Response Form". For questions call 858-232-2672.

Root cause

Component design/selection

Status

Terminated

Product code

HXC

Quantity affected

148

Distribution

Worldwide Distribution - US Nationwide

Date initiated

2015-03-12

Date posted

2015-04-20

Date terminated

2015-09-16

Location

Broomfield, CO